UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031774 |
|---|---|
| Receipt number | R000036272 |
| Scientific Title | predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2022/09/20 05:45:50 |
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Basic information
Public title
predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Acronym
predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Scientific Title
predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Scientific Title:Acronym
predict of pulmonary circulation dynamics during exercise in patients with pulmonary hyper tension
Region
| Japan |
Condition
Condition
pulmonary hyper tension
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an index to predict rising pulmonary artery pressure during exercise in patients with pulmonary hypertension from the time of rest
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mPAP-co slope during exercise
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Case in which right heart catheter examination with exercise load was performed and consent regarding use of the examination result was obtained
Key exclusion criteria
Case in which agreement on use of examination result was not obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Tobita |
Organization
kyorin university hospital
Division name
Department of Rehabilitation
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611, Japan
TEL
0422-47-5511
skazuki1107@gmail.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Tobita |
Organization
kyorin university hospital
Division name
Department of Rehabilitation
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611, Japan
TEL
0422-47-5511
Homepage URL
skazuki1107@gmail.com
Sponsor or person
Institute
kyorin university hospital department of rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Japanese association of cardiac rihabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
no
Name of secondary funder(s)
no
IRB Contact (For public release)
Organization
kyorin university
Address
6-20-2, shinkawa, mitaka, tokyo, japan
Tel
0422-47-5514
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏林大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kyorinmed/52/4/52_167/_pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kyorinmed/52/4/52_167/_pdf
Number of participants that the trial has enrolled
30
Results
Increased pulmonary artery pressure during exercise was associated with increased ventilation at rest.
Results date posted
| 2022 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients in the exercise PH group (71 years:range 61-76) were significantly older than those in the non-exercise PH (46 years: range 37-55). We found no significant differences in each group for height, weight, PH background factors, and several cases receiving continuous intravenous injections of medical agents or type of oral medication. The mPAP-CO slope was 4.9 (range, 4.0-6.4) and 2.0 (range, 1.8-2.5) for the exercise PH and non-exercise PH groups, respectively.
Participant flow
Various evaluations during hospitalization for follow-up right heart catheterization purposes
Adverse events
none
Outcome measures
association between exercise-induced ph and resting parameters.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2018 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036272
